Medicines and Healthcare Products Regulatory Agency

Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 2000
Web: www.mhra.gov.uk

From 1 April 2003, the Medicines and Healthcare products Regulatory Agency (MHRA) replaced the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA). The MHRA is an Executive Agency of the Department of Health with trading fund status.

The MHRA's mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.

The MHRA's aims and objectives.

• Protecting public health through regulation, with acceptable risk:benefit profiles for medicines and devices.
• Promoting public health by helping people who use these products to understand their risks and benefits.
• Improving public health by encouraging and facilitating developments in products that will benefit people.
• Maintaining rigorous authorisation and inspection programmes.
• Maintaining and developing pro-active surveillance and enforcement programmes.
• Communicating authoritative and reliable information and advice to improve public and professional awareness.
• Engaging with and influence other government bodies and European and worldwide regulators concerned with medicines or medical devices.
• Supporting innovation and product development, offering constructive and impartial advice to scientific communities and health services.
• Minimising the cost of regulation so far as is compatible with our public health role; and run a successful business with a skilled and equipped workforce dedicated to the Agency's aims.

Key activities:

• Regulating medical devices.
• Licensing of medicines before marketing and subsequent variations.
• Regulation of clinical trials.
• Operating adverse incident reporting system for medical devices.
• Issuing safety warnings.
• Responsibility for reporting, assessment and communications of defective medicines.
• Monitoring of medicines and acting on safety concerns after marketing.
• Ensuring compliance to standards of pharmaceutical manufacture and wholesaling.
• Enforcement of requirements.
• Evaluating medical devices to inform purchasing and encourage safe use.
• Managing the General Practice Research Database (GPRD).
• Setting quality standards for drug substances through the "British Pharmacopoeia".
• Providing advice and guidance on medicines and medical devices.